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The US Food and Drug Administration disclosed on Monday that Patrizia Cavazzoni, who has been heading the unit on an interim basis, was appointed the permanent Director of the agency's Center for Drug Evaluation and Research (CDER). 13 April 2021
Pharmaceutical
Belgium’s Oxurion has received a capital commitment of up to 30 million euros ($35 million) from Paris-based investor Negma Group. 6 April 2021
Pharmaceutical
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund), and Panacea Biotec, an Indian vaccine and pharmaceutical producers, have announced a collaboration to produce 100 million doses per year of Sputnik V, the COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology. 5 April 2021
Pharmaceutical
Japanese pharma major Astellas Pharma today announced that Astellas and Viatris Pharmaceuticals Japan have agreed to end the co-promotion of a hypercholesterolemia and familial hypercholesterolemia treatment Lipitor (atorvastatin) Tablets 5mg, 10mg, manufactured and sold by Astellas and co-promoted by both companies in Japan on July 31, 2021. 1 April 2021
Pharmaceutical
EUSA Pharma has appointed Carsten Thiel as chief executive, replacing Lee Morley, who is stepping down after six years in the role. 31 March 2021
Pharmaceutical
Following feedback from the US Food and Drug Administration in a pre-New Drug Application meeting, Odonate Therapeutics has concluded that the clinical data package for tesetaxel is unlikely to support FDA approval. 23 March 2021
Pharmaceutical
Oncology specialist Aura Biosciences has raised $80 million in a financing round led by Matrix Capital Management and Surveyor Capital. 23 March 2021
Pharmaceutical
Just in the last seven days, the Russian Direct Investment Fund (RDIF) has announced production contracts with three Indian manufacturers for more than 300 million people doses of Sputnik V a year. 22 March 2021
Pharmaceutical
UK pharma major AstraZeneca yesterday announced the death of José Baselga, executive vice president oncology R&D, and member of its senior executive team. 22 March 2021
Pharmaceutical
Japanese firm Nippon Shinyaku has entered into an exclusive license agreement for the development and commercialization of tagraxofusp in Japan with family-owned Italian drugmaker Menarini. 19 March 2021
Pharmaceutical
Nordic Nanovector has appointed Peter Braun, a former Roche executive with three decades of experience at the company, as chief executive officer. 18 March 2021
Pharmaceutical
The European Medicines Agency (EMA) continues to stress that it favors going ahead with the roll-out of COVID-19 Vaccine AstraZeneca despite its distribution being halted in 11 member states due to a number of events of blood clots among vaccinated people. 16 March 2021
Pharmaceutical
Takeda Pharmaceutical today announced that Milano Furuta, Takeda’s current global corporate strategy officer and chief of staff, has been appointed as president of the Japan Pharma Business Unit (JPBU) effective April 1, 2021. 15 March 2021
Pharmaceutical
The US regulator is proceeding to review a submission for Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for adults with insomnia. 10 March 2021
Pharmaceutical
Japan’s Sumitomo Dainippon Pharma today announced that it will post an impairment loss for the fiscal year ending March 31, 2021. 5 March 2021
Pharmaceutical
Merck & Co announced today that the US Food and Drug Administration has accepted for review the company’s New Drug Application (NDA) for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. 1 March 2021
Pharmaceutical
The US Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 28 February 2021
Pharmaceutical
Fortress Biotech partner company, Cyprium Therapeutics, and Sentynl Therapeutics, a USA-based specialty pharma company owned by the India’s Zydus Group, today announced the execution of an asset purchase agreement to commit development funding for and acquire Cyprium’s proprietary rights to CUTX-101, its copper histidinate product candidate that has the potential to be the first Food and Drug Administration-approved treatment for Menkes disease. 24 February 2021
Pharmaceutical
US President Joe Biden's nominee to lead the powerful Department of Health and Human Services appeared Tuesday before the Senate in the first of two hearings, with allies fanning out to defend him as Republicans mobilize to tank his nomination, reported NBC News. 24 February 2021
Pharmaceutical
Pfizer and BioNTech’s BNT162b2 can cut the number of symptomatic COVID-19 infections by 94%, according to real-world data from Israel. 16 February 2021
Pharmaceutical
Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024
Pharmaceutical
USA-based clinical-stage biopharma Traws Pharma saw its shares leap more than 150% to $12.57 as it announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Pharmaceutical
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
Pharmaceutical
Spanish plasma-based medicines maker Grifols has announced disappointing top-line data from its Phase III PRECIOSA clinical trial evaluating the potential of long-term albumin treatment with Grifols Albutein on patients with decompensated cirrhosis and ascites, sending its share down 2.4% to 9.27 euros on Friday. 23 December 2024
Pharmaceutical
Denmark has introduced a three-year agreement to regulate price ceilings for hospital medicines, aimed at providing stability for the public healthcare system and pharmaceutical companies. 23 December 2024
Pharmaceutical
French pharma major Sanofi says it has entered into a new chapter of the collaboration with South Korean firm SK bioscience in pneumococcal vaccines, with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. 23 December 2024
Pharmaceutical
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations. 23 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved an expanded indication for Imcivree (setmelanotide), from Boston, USA-based Rhythm Pharmaceuticals, to include children as young as two years old. 23 December 2024
Pharmaceutical
US pharma giant Pfizer on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. 23 December 2024
Pharmaceutical
Among significant research news last week, UK drug developer PureTech released positive new Phase IIb data on its deupirfenidone in idiopathic pulmonary fibrosis. France’s Sanofi and Israel-based Teva Pharmaceutical Industries announced encouraging new Phase IIb data for their duvakitug in inflammatory bowel disease. Meanwhile, Vertex Pharmaceuticals released Phase II results for its investigational sciatica treatment suzetrigine that failed to impress. Also of note, AbbVie announced strong Phase III results of tavapadon in early Parkinson’s disease. 22 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Duvyzat (givinostat) to treat Duchenne muscular dystrophy (DMD). 22 December 2024
Pharmaceutical
San Diego, USA-based Neurocrine Biosciences today announced the launch of its Crenessity (crinecerfont) in the USA. 20 December 2024
Pharmaceutical
Denmark’s Zealand Pharma has been hit with a complete response letter (CRL) from the US regulator for glepaglutide, a long-acting GLP-2 analog. 20 December 2024
Pharmaceutical
Denmark’s Novo Nordisk today announced headline results from REDEFINE 1, a Phase III trial in the global REDEFINE program, which it said were positive, but failed to impress investors, who pushed the firms shares down 19% to 601.30 kroner. 20 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). 20 December 2024
Pharmaceutical
US pharma giant Merck has announced top-line results from two pivotal Phase III trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL). 20 December 2024
Pharmaceutical
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
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